Table 4.
Stool characteristics in study evaluable (EV) subjects *.
| Study Variables | Treatment Groups | ||
|---|---|---|---|
| CF | EF1 | EF2 | |
| Mean Rank Stool Consistency Score ** (Primary Study Variable) | |||
| Days 1–14 | 2.5 ± 0.1 (51) | 2.6 ± 0.1 (57) | 2.5 ± 0.1 (57) |
| Days 15–35 | 2.6 ± 0.1 (40) | 2.7 ± 0.1 (41) | 2.5 ± 0.1 (46) |
| Stool Frequency, # stools/day | |||
| Days 1–14 | 2.9 ± 0.3 (48) | 3.3 ± 0.3 (55) | 3.1 ± 0.3 (56) |
| Days 15–35 | 2.1 ± 0.2 (40) | 2.7 ± 0.3 (41) | 2.7 ± 0.3 (46) |
| Percent Watery Stools, % | |||
| Days 1–14 | 11.3 ± 2.6 (51) | 16.3 ± 3.4 (57) | 12.7 ± 2.8 (57) |
| Days 15–35 | 8.9 ± 2.0 (40) | 11.4 ± 3.4 (41) | 13.3 ± 3.4 (46) |
| Percent Loose/Mushy Stools, % | |||
| Days 1–14 | 47.7 ± 4.7 (51) | 32.9 ± 3.9 (57) | 39.5 ± 3.7 (57) |
| Days 15–35 | 40.4 ± 5.5 (40) | 31.7 ± 4.5 (41) | 41.0 ± 4.7 (46) |
| Percent Soft Stools, % | |||
| Days 1–14 | 26.7 ± 3.7 (51) | 34.8 ± 3.9 (57) | 37.5 ± 4.1 (57) |
| Days 15–35 | 35.3 ± 5.1 (40) | 40.1 ± 4.3 (41) | 30.3 ± 4.6 (46) |
| Percent Formed Stools, % | |||
| Days 1–14 | 10.8 ± 3.0 (51) | 10.4 ± 1.9 (57) | 9.0 ± 2.3 (57) |
| Days 15–35 | 11.4 ± 2.8 (40) | 15.5 ± 2.9 (41) | 12.6 ± 2.9 (46) |
| Percent Hard Stools, % ‡ | |||
| Days 1–14 | 3.5 ± 1.7 (51) | 5.6 ± 2.5 (57) | 1.3 ± 0.9 (57) |
| Days 15–35 | 4.0 ± 2.2 (40) | 1.4 ± 0.6 (41) | 2.8 ± 1.4 (46) |
Abbreviations: CF = Control formula, EF1 = Experimental formula 1, EF2 = Experimental formula 2; * Values are mean ± SEM (n); ** Mean Rank Stool Consistency Score: 1 = watery, 2 = loose/mushy, 3 = soft, 4 = formed, 5 = hard; ‡ Percent of Hard Stools at d1-14; EF1 > EF2 (p = 0.0207).